1 / 42

OneBreath: A Non-Invasive Tool for Lung Cancer Diagnosis

OneBreath is a patented, quantitative breath test developed by BDx Inc. for the safe, reliable, and low-cost diagnosis of lung cancer. It offers a faster, more accessible, and accurate alternative to current diagnostic methods, reducing the need for expensive CT scans, invasive procedures, and exposure to radiation.

billg
Download Presentation

OneBreath: A Non-Invasive Tool for Lung Cancer Diagnosis

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Confidential Property of BDx Inc. OneBreath

  2. The OneBreath test: patented, quantitative Team: Bousamra MD Ennis, CEO/Pres Nantz PhD (Chemist) Duncan (Eng. Reg) Gori PhD (Lab) Rich MD (CMS-Reimb.) Confidential Property of BDx Inc. OneBreath

  3. The Lung Cancer Problem Lung Cancer is the leading cause of cancer death in the United States NCI statistics 2013: Deaths — 159,480 Early diagnosis key to long term survival Lung Cancer Screening Trial CT Scanning reduces mortality by 20 % suspicious pulmonary nodule Disadvantages Expense — $3 billion per year in US Exposure to repeated radiation Low participation (15%) False positive rate (96%) patient CT scan

  4. Current Tools for Diagnosis of Lung Cancer Post-CT Scan Procedures Bronchoscopy Surgery NeedleBiopsy COST = >$40,000 COST = $7,000 COST = $7,000 Clinical niche: A safe, non-invasive, reliable and low cost tool for lung cancer diagnosis is needed.

  5. The Complexity of Human Breath The composition of breath ranges from hydrogen to more than 1000 volatile organic compounds Pauling L, et al.,(1971) Proc Natl Acad SciUSA 68: 2374 – 2376.

  6. Key Attributes of Breath Analysis Volatile Organic Compounds (VOCs) • Capture • Concentration • Identification • Diagnosis

  7. Applications of Breath Analysis for Lung Cancer Detection • Screening • Post lung cancer resection monitoring • Indeterminate pulmonary nodules

  8. Breath Diagnostics, Inc. • Selective capture and analysis of volatile carbonyl compounds 2-Butanone Benzaldehyde; 2,3-Butanedione n-Pentanal, 3- hydroxy-2-Butanone Hexanal, 2-Methyl-3-Hexanone Octanal Amann et al. BMC Cancer 2009, 9, 348. Phillips et al. Clinica Chimica Acta 2008, 393, 76. Miekischet al. Inter. J. Cancer 2010, 126, 2663

  9. Silicon Chip Nanotechnology 2011: Analyst136, 4662–4666 2012: Analytical Chemistry84, 1288–1293 2013: Sensors and Actuators 180, 130–136 2014: Cancer Medicine3, 174–181; J. Thorac. Cardiovasc. Surg.148, 1074–1081 2015: Analytical Methods 7, 6027–6033; Lung Cancer, 89, In Press

  10. VOC Capture and Analysis US Patent No. 8,663,581 ATM adducts in MeOH, analysis via direct injection ATM covalent adduct micropillar US Patent, No. 61/871,024 healthy controls conc. (nmol/L) 0.208 1.38 0.085 0.001

  11. Quantitative Analysis of Exhaled Carbonyls Clinical Mass Spectrometry Collected Breath MS Data Diagnosis ATM-acetone-d6 ATM

  12. Elevated Cancer Markers Indicate Cancer

  13. The Number of ECMs Differentiate Lung Cancer and Benign Disease 72:2 (97.3 %) • Bousamra et al. 2014 J. Thorac. Cardiovasc. Surg. 148, 1074–1081

  14. PET / ECM Comparisonfor Early Lung Cancer Detection All tumors >2.5cm test breath positive (2-4 ECM) M. Bousamra et.al AATS Presentation, April 2014

  15. Control vs. Lung Cancer n = 202 control, 156 ca ≥ 1 ECM E. Schumer et.al AATS Presentation April, 2015

  16. Post-Resection Data (n=38) E. Schumer et.al STS Presentation January, 2016

  17. Validation • Markers are not smoking related • Control/benign/cancer progression of concentration levels • Normalization post-resection

  18. Tactics and Strategy: Transitioning from research to a healthcare business • Clinical engineering development and production • Mass spec analysis – US MedSci, New Albany • Clinical Research Organization – Novella Clinical et al. • Comprehensive multi-center trials encompassing the various geographies, settings and ethnicities' of America, Europe, China • nodules, post-resection, screening

  19. The Problem • Current lung cancer diagnostic tools are costly and ineffective Expensive Initial CT scans cost $300 or more and all positive CT scans require at least one diagnostic follow-up procedure (biopsies, bronchoscopies, or surgery) which can cost more than $7,000 each. Less Effective CT scans expose the patient to 20x more radiation than a Chest X-ray. Furthermore, CT scans do not indicate if spots on the lung are cancerous. High False-Positive Rate: As many as 40/100 high-risk smokers will have concerning results from a CT scan, but only 2-3 will actually have lung cancer. • High Mortality Rate Lung cancer has the highest mortality among all cancers. Patients avoid existing early detection examinations due to the expensive nature of current diagnostic methods, associated radiation exposure, invasive procedures, and the significant time delay between testing and diagnosis.

  20. The Solution Lung cancer detection by breath analysis Safer & Quicker Results The OneBreath technology yields results in less than 24 hours. The microreactor captures specific cancer markers from a single breath and does not expose patients to radiation. More Accessible More people will be examined because the test is safe and convenient. Ultimately, breath tests will be performed at local pharmacies and primary care centers. • More Accurate, Less Expensive Breath analysis is 2x more predictive than a PET scan. PET scans are routinely administered as follow-ups to CT scans and cost 5–10x more than a breath test.

  21. How It Works Step 1 Step 2 Step 3 Breath Collection Breath Processing Results in 24 Hours Patients exhale into a non-reactive bag in one easy breath. The breath sample is processed onsite by connecting the bag to an evacuation station. A silicon microreactor isolates and concentrates the cancer biomarkers. • 24 hours after the breath is collected, results are available to the patient.

  22. CT Scan Comparison Time to Lung Cancer Diagnosis Key Differences AFFORDABLE NON-INVASIVE CONVENIENT QUANTIFIABLE PRECISE 3 Months 24 Hours CT Scans

  23. Total Addressable Market (US) Pneumonia vs. Viral Illness Tuberculosis Pneumoconiosis Cystic Fibrosis ________________________________ 432K – Breast & Prostate $172B3 Total annual expenditure on medical devices and in-vitro diagnostics 286K – Colorectal, Bladder & Kidney 151K – Liver, Pancreatic & Thyroid 198K –Endometrial, Leukemia & Non-Hodgkin Lymphoma ________________________________ 400K – IPNs identified 234K – Lung / Bronchus $177B2 Cost of Cancer Care in U.S. 8.6MM – at high risk for LC No. of US cases – Disease Type • Annual Revenue for 100% Market Penetration • American Cancer Society: Cancer Facts and Figures 2018 • J Natl Cancer Inst. 2011;103:117-28 • Estimates of Medical Device Spending in the United States – Gerald Donahoe and Guy King

  24. Breath Analysis vs. Current Methods (IPN) More affordable, faster, safer than current methods

  25. Competitive Landscape Breath Diagnostics Has Stronger Analysis & Instant Results Quantitative Kentucky - 2014 Prolonged Breath Collection Single Breath Collection United Kingdom - 2004 Florida - 2010 United Kingdom - 2014 Qualitative (Pattern Recognition) Canada - 2005 New Jersey - 1994 Israel - 2014

  26. Traction + Research Data 800 Subjects studied at multiple sites. Our studies include patients with cancer or benign disease, using smokers and non-smokers as controls. Peer-Reviewed Publications Our findings have been published in 10 peer-reviewed journal articles and have been presented at national and international conferences. Best-in-Class Technology No other company has as much clinical data published on breath analysis technology. The BDxOneBreath test has a 94% sensitivityfor lung cancer detection in at-risk subjects. Patents Two US patents have been granted and one currently is pending. Additionally, BDx has submitted multiple international patent applications. $2.5M Reputable Funding Development of the technology at UofL was funded by many recognized foundations, such as the Bill & Melinda Gates Foundation. $2MM has been received from foundations and $550K through seed funding. Total Funding Received

  27. Revenue & Margins We Sell OneBreath Kits & Evacuation Stations $130 $3K OneBreath Kit Evacuation Station $25 $800 • COGS At Scale OneBreath Kit Evacuation Station

  28. Timeline & Milestones Present 2015 - 2017 Q1-Q3 2019 Q3 2019 2014 Q4 2022 $2.5M Funding Prototype Build Initial Clinical Data ProductDevelopment Independent Clinical Validation FDA Enabling Trials FDA Trials Begin Founded Revenue Key Milestones Value Inflection Points Q3 2018 Establish Quality Systems Develop Regulatory Plan Q4 2018 510k DeNovo Approval Independent Clinical Trial Q3 2019 Launch trial for IPN characterization Q1 2020 Launch trial for post resection monitoring Q4 2020 Launch trial for screening Q3 2021First report for IPN Clinical Trial Q1 2022IPN characterization trial completion

  29. Capital Raise $7MM Objectives & Use of Funds Product Development Finalize development of the second-generation OneBreath test kit to conform to appropriate quality systems Clinical Validation Validate the OneBreath test at multiple clinical sites using Contract Research Organizations Obtain De-Novo 510(k) Approval1 Conduct a clinical trial (250 subjects, 6 months) to obtain FDA approval for the OneBreath test FDA Clinical Trial Conduct a limited clinical trial to estimate and appropriately power formal multicenter FDA clinical trials for all applications 1 510(k) is a premarket submission made to the FDA to demonstrate that a device is safe and effective for the market

  30. 8th Edition Lung Cancer Staging • Clinical • Pathological • Radiological The goal is for staging to accurately predict survival over time. Confidential Property of BDx Inc. OneBreath

  31. Pancoast Tumors Confidential Property of BDx Inc. OneBreath

  32. Confidential Property of BDx Inc. OneBreath

  33. Confidential Property of BDx Inc. OneBreath

  34. Confidential Property of BDx Inc. OneBreath

  35. Confidential Property of BDx Inc. OneBreath

  36. Confidential Property of BDx Inc. OneBreath

  37. Confidential Property of BDx Inc. OneBreath

  38. Confidential Property of BDx Inc. OneBreath

  39. Clinical Chip Design-Engineering Progeress

  40. Strategic Investment Plan for Clinical Trials and LDT Development Confidential Property of BDx Inc. OneBreath

  41. Clinical Evacuation System

  42. Confidential Property of BDx Inc. OneBreath

More Related